The Most Important Compliance Best Practices You Need to Know

In May 2012, OSHA issued citations to a number of companies for violating safety regulations governing process safety management, documentation and recordkeeping, equipment inspections, lead contamination and grain elevators. This article discusses the most notable citations and violations that were issued to companies recently by the safety agency.

The Department of Justice (DOJ) and the Securities & Exchange Commission (SEC) accused the parent company (Smith & Nephew PLC, a global medical devices and products company headquartered in London) and its US and German subsidiaries of violating the provisions of the Foreign Corrupt Practices Act (FCPA).

UK’s Financial Services Authority (FSA) fined Coutts Bank GBP 12.5 million for not having adequate checks in place to prevent money laundering practices by their customers. The FSA reviewed Royal Bank of Scotland’s Coutts Bank for a period of three years between 2007 and 2010. The fine was reduced to 70 per cent of that amount – GBP 8.75 million since Coutts Bank agreed to an early settlement. This article discusses the background and best practices that could have prevented this punitive action against Coutts.

The US Department of Labor’s OSHA or Occupational Safety and Health Administration has issued a warning to Hyatt Hotels Corp., subsequent to its year-long onsite inspection of the company. While Hyatt’s offenses were not so serious as to warrant a citation, it was served a letter by OSHA. This article discusses the contents of the letter and OSHA's concerns.

Power plants, through their coal-powered plants and refineries, account for most (40%) of the carbon dioxide emissions in the US. Coal-based power plants burn coal in order to generate electricity. Refineries use crude petroleum to extract gasoline, kerosene and oth-er oil products.This article discusses how the EPA's new greenhouse gas rule affects new power plants.

The FDA’s latest rule on New Dietary Ingredient Notification has created confusion on when, who and how the submissions are to be done to the agency. This article details some of the most important issues addressed in the new rule.

When it comes to immunogenicity testing of biotech products and derivatives, a number of risk factors have to be considered. This article describes these risk factors and who should consider them during the testing process.

The largest retailer in the world, the US multinational company (MNC) Walmart operates in 15 countries around the world with 8,500 stores. An article that appeared in April 2012 in New York Times has accused the largest private employer in the world of indulging in acts of bribery in Mexico.

Employees and workers spend a good part of their time at workplaces. Hence it is important that the environment in which they work is hygienic –- therein arises the relevance of Indoor Air Quality or IAQ. OSHA has specific requirements for indoor air quality and these have to be followed to ensure worker health and safety.

Since workers in the chemical sector handle harmful chemicals they are exposed to health risks. There are certain standards and procedures in place to educate these workers about the safest ways to handle these containers. Currently, for chemical manufacturers and importers in the US, OSHA has put in place a Hazard Communication Standard (HCS).

UK’s Financial Services Authority (FSA) expects UK-based investment banks to maintain effective systems of control to check financial crime risk in the firm, i.e., the risk that anyone in the firm or on behalf of the firm engages in bribery or corruption. The FSA visited 15 firms – eight major, global investment banks and other smaller firms that were into investment banking activities to assess the extent of compliance with its instructions on Anti-bribery and Corruption (ABC) controls.

Shadow banking refers to the activities, practices and transactions of all financial entities that are outside the purview of the banking regulator. The whole range of leveraged non-bank investment conduits, vehicles and structures fall under shadow banking activities. The European Union (EU) proposes to further regulate shadow banking activities for a number of reasons. This article explains these reasons and the likely impact of the regulations.

Automation often seems the best choice for medical device manufacturers in order to ensure that variations in processes are avoided and quality consistency is attained. However, automating blindly comes with high risks and therefore a number of steps must be taken to avoid such risks. In this article, Dev Raheja, a medical device quality expert, explains the risk management principles and processes that must be taken into consideration before implementing manufacturing automation.

Dietary supplements in the US are regulated by the FDA and USDA. Under the Dietary Supplements Health and Education Act of 1994 (DSHEA), the Office of Dietary Supplements at the NIH was created. This article discusses the cGMP issues that dietary supplement makers face and the best practices to overcome these.

Several surveys conducted in 2009 showed that around 61% of American adults get their health information from the internet. Around 79% of patients also believe that they learn more about medicines from the manufacturers’ social media channels.

This uptick in numbers of people who use the internet for more information on regulated products has forced the FDA to address the issue of using social media and the internet to disseminate information on regulated products.
 

Hershey owns Eastern Distribution Center III, a vast plant in Palmyra. The chocolate company hired Exel, a logistics contractor that has operations in 511 facilities in the United States and Canada, to run the plant. Exel in turn hired a subcontractor, SHS Staffing Solutions that hired foreign students as temporary workers to pack chocolates. Following a six-month investigation, OSHA Director fined Exel USD 283,000 for job safety violations.

This article details the reasons why the contractor was fined and the best practices that should have been followed to avoid similar violations.

The Advanced Measurement Approach (AMA) framework seeks effective governance, risk capture, assessment and quantification of operational risk exposure. Banks have the freedom though, to develop operational risk measurement and management programs, processes, and tools that are appropriate to their activities, business environment, and internal controls.

This article details the elements that have to be included in a model framework and the best practices for compliance.

According to the Securities and Exchange Commission (SEC), Biomet Inc violated the provisions of the Foreign Corrupt Practices Act (FCPA). The violation occurred in the form of bribes that Biomet’s subsidiaries and their agents paid to public doctors in Argentina, Brazil and China for almost a decade in order to bag business.

This article details the allegations against Biomet and the compliance best practices that have to be followed to avoid similar charges.

The Securities and Exchange Commission (SEC) and Commodity Futures Trading Commission (CFTC) have jointly announced a rule proposal to help protect investors from identity theft. This is to be done by ensuring that SEC- and CFTC- regulated entities detect and respond to warning signs or red flags.

This article details best practices that firms can follow in order to ensure compliance with the proposed rule.

How can various departments work together to ensure medical device design projects are executed efficiently and successfully? This responsibilitiy lies with the management - but what are the best practices that can be followed?

Dev Raheja, a renowned medical device quality expert, explains all in this article.